AccessGUDID - DEVICE: Unassayed Testosterone QC Material (04049325014879)

GUDID

Device Identifier (DI) Information

Brand Name: Unassayed Testosterone QC Material
Version or Model: 30108902
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30108902
Company Name: IBL International GmbH

Primary DI Number: 04049325014879
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312694785 *Terms of Use

Device Description: Unassayed Testosterone QC Material - 20 mL

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
54183	Free testosterone IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of free testosterone in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 30378018-ecc2-41dd-8255-d1f5eaa1b709
Public Version Date: April 11, 2024
Public Version Number: 3
DI Record Publish Date: December 29, 2020